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GXPNews.com - FDA News and Announcements - October 1, 2007 - October 5, 2007

The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)
Distributed by the worlds leader in Federal Regulations, GMP Publications & FDA.COM - John Cuspilich, Editor

Center for Drug Evaluation &
Research (CDER) News

(CBER) Center for Biologics Evaluation & Research

Center for Device & Radiological Health (CDRH)

Federal Register - Meetings, Notices, & Rule Changes

View CDER Handbooks

View CBER Handbooks

View CDRH Handbooks

October 5, 2007

Cyber Warning Letters (updated)

October 4, 2007

FDA announces an initiative to bolster its generic drug program
FDA announces the award of a contract to assist with the transformation of FDA's Center for Drug Evaluation and Research
New and Generic Drug Approvals
- Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision
- Duetact (pioglitazone HCl plus glimepiride) Fixed-dose Combination Tablets, Takeda Global, Formulation Revision
- GEODON (ziprasidone HCl) Capsules, Pfizer Inc., Labeling Revision
- GEODON (ziprasidone mesylate) Injection, Pfizer Inc., Labeling Revision
- Linezolid Tablets, Teva Pharma, Tentative Approval
- Metoprolol Tartrate Injection, Sandoz Pharma, Approval
- NuvaRing (etonogestrel/ethinyl estradiol) Vaginal Ring, Organon Inc., Labeling Revision
- Omnipaque (iohexol) Injection, GE Healthcare, Labeling Revision

October 3, 2007

Drugs@FDA Downloadable Data Files (updated)
FDA acts to ensure that thyroid drugs don’t lose their potency before the expiration date. Levothyroxine Information

October 2, 2007

CDER Organization Charts [HTML] [PDF] (updated)
Guidance for Industry: Comprehensive List of Guidance Documents
Guidance for Industry: New/Revised/Withdrawn List for 2007
New and Generic Drug Approvals
- Butisol Butabarbital Sodium Oral Solution, Medpointe Pharma, Labeling Revision
- Delsym (dextromethorphan polistirex) Extended-Release Suspension, Adams Respiratory, Formulation Revision
- LAMISIL (terbinafine hydrochloride) Oral Granules, Novartis Pharma, Approval
- Nevirapine Tablets, Emcure Pharma, Tentative Approval
- Ofloxacin Otic Solution, Apotex, Approval
- PROVERA (medroxyprogesterone acetate) Tablets, Pfizer Inc., Labeling Revision
- Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly, Efficacy Supp. w/Clinical Data
- TAXOTERE (docetaxel) Injection Concentrate, Sanofi-aventis, New or Modified Indication
Paragraph IV Patent Certifications (updated)
Notice of Violation Letter: Cymbalta

October 1, 2007

FDA issues an Early Communication of an Ongoing Safety Review for bisphosphonates
Investigational Human Drugs: Clinical Investigator Inspection List (CLIIL) (updated)
New and Generic Drug Approvals
- Amlodipine Orally Disintegrating Tablets, Synthon Pharma, Approval
- Amlodipine Besylate Tablets, Watson Labs, Approval
- AZOR (amlodipine and olmesartan medoxomil) Tablets, Daiichi Sankyo, Approval
- Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision
- Clopidogrel Bisulfate Tablets, Roxane Labs, Tentative Approval
- Dovonex Scalp Solution, Warner Chilcott, Labeling Revision
- Dovonex Cream, Warner Chilcott, Labeling Revision
- Dovonex Ointment, Warner Chilcott, Labeling Revision
- EPIVIR-HBV (lamivudine) Tablets, GlaxoSmithKline, Labeling Revision
- EPIVIR-HBV (lamivudine) Oral Solution, GlaxoSmithKline, Labeling Revision
- Levophed (norepinephrine bitartrate) Injection, Hospira Inc., Package Change
- Morphine Sulfate Extended-release Tablets, KV Pharma, Approval
- Taclonex Ointment, Warner Chilcott, Labeling Revision
Notice to Applicants Submitting Direct-to-Consumer Television Advertisements for Advisory Review to CDER/CBER for Fiscal Year 2008

CDER Drug Links

Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza; Availability
Posted: 10/4/2007

Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil) - Updated Package Insert
Posted: 10/3/2007

Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update
Posted: 10/3/2007

Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) - Revised Labeling
Posted: 10/3/2007

Blood Products Advisory Committee Roster - Updated
Posted: 10/2/2007

Vacancy Announcement - Consumer Safety Technician, DVRPA/OVRR
Posted: 10/1/2007

Substantially Equivalent 510(k) Device - AllSet Gold SSP - Invitrogen Corp
Posted: 10/1/2007, Clearance Date: 9/26/2007

Substantially Equivalent 510(k) Device - S-Monovette ACD-A Blood Collection System - Cytomedix, Inc
Posted: 10/1/2007, Clearance Date: 9/21/2007

Substantially Equivalent 510(k) Device - AutoloGel System - Cytomedix, In
Posted: 10/1/2007, Clearance Date: 9/20/2007

BER Links

October 5, 2007
	510(k) Final Decisions - September 2007

October 4, 2007
	Circulatory System Devices Panel Advisory Meeting, September 19-20, 2007 - Brief Summary, Roster, Questions, Slides
	Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electrocardiograph Electrodes
	Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability.
	Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions
	Federal Register: Guidance for Industry and Food and Drug Administration Staff; Biological Indicator Premarket Notification Submissions; Availability.
	Federal Register: Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls.

October 2, 2007
	Federal Register: Agency Emergency Processing Under OMB Review; Medical Device User Fee Amendent of 2007; Foreign Small Bussiness Qualification Certication Form FDA 3602A.

Medical Device Links

Industry Assistance

About CDRH

Device Program Areas

CFR Rule Changes
this week - 522 - 556 - 558

Friday, October 5, 2007

RULES
Animal drugs, feeds, and related products:
     Polysulfated glycosaminoglycan,
     56896 [E7–19729]   [TEXT]  [PDF]
     Ractopamine,
     56896–56898 [E7–19732]   [TEXT]  [PDF]

Thursday, October 4, 2007

PROPOSED RULES
Medical devices:
     Cardiovascular devices—
     Electrocardiograph electrode; special controls designation,
     56702–56704 [E7–19580]   [TEXT]  [PDF]

NOTICES
Food additive petitions:
     Dean Foods Co.,
     56768–56769 [E7–19576]   [TEXT]  [PDF]

Meetings:
     Behind-the-counter availability of drugs,
     56769–56770 [E7–19329]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     Biological indicator premarket notification submissions,
     56770–56771 [E7–19573]   [TEXT]  [PDF]
     Electrocardiograph electrodes; Class II special controls,
     56771–56772 [E7–19578]   [TEXT]  [PDF]
     Vaccines used for pandemic influenza; safety and effectiveness assessments development,
    56772–56773 [E7–19577]   [TEXT]  [PDF]

Wednesday, October 3, 2007

NOTICES

Agency information collection activities; proposals, submissions, and approvals,
56361 [E7–19454]   [TEXT]  [PDF]
56361–56362 [E7–19457]   [TEXT]  [PDF]

Committees; establishment, renewal, termination, etc.:
     Reagan-Udall Foundation,
     56362–56363 [07–4882]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     Nonclinical electronic study data submission; pilot project,
     56363–56364 [E7–19468]   [TEXT]  [PDF]

Tuesday, October 2, 2007

NOTICES
Agency information collection activities; proposals, submissions, and approvals,
56076–56077 [E7–19350]   [TEXT]  [PDF]
56077–56078 [E7–19411]   [TEXT]  [PDF]

Meetings:
     Science Board,
     56078–56079 [E7–19349]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     Swine respiratory disease claims; effectiveness studies; recommended study design and evaluation,
     56079 [E7–19412]   [TEXT]  [PDF]

Monday, October 1, 2007

NOTICES
Human drugs:
     Hydrocodone-containing products; enforcement action dates,
     55780–55784 [E7–19340]   [TEXT]  [PDF]

Meetings:
     Nonprescription Drugs and Pediatric Advisory Committees,
     55784 [E7–19332] [TEXT]  [PDF]

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